Psychiatrists' Failure to Inform: Is There Substantial Financial Exposure?

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1 Emical Human Psychology and Ps)'chiarry, Volume 9, Number 2, 2007 Psychiatrists' Failure to Inform: Is There Substantial Financial Exposure? James B. Gottstein, Esq., JD PsyclJRights Psychiatrists regularly fail to obtain informed consent by not (ully informing their patients of the risks ofpsychotropic drugs ;:IS well <as overstating their benefits. As the wave of law suits against manufacturers for failure to warn wane, will such psychiatrists be next <lnd do they risk substantia! Iiability~ Keywords: informed consentj involuntary medication; antipsychotics; civil rights; battery; perjury Psychiatric drugs are causing huge amounts of physical harm, including severely lim ired lives and early dearh. Tragically, rhis is nor offser by corresponding benefirs, because the ability of psychiatric drugs to successfully treat the conditions for which they are prescribed is limited. In fact, they are often counterproductive. This is particularly true of the neuroleptics, often also called by the misnomer "antipsychotics." It is also true of the selective serotonin reuptake inhibitor (SSRl) antidepressants and their cousins, as well as the stimulants used to treat children and now adults with attention deficit hyperac riviry disorder (ADHD). In addirion, rhese anridepressanr and ADHD drugs cause people [Q become psychotic in a substantial percentage ofcases, which often leads to misdiagnos. ing an underlying mental illness and results in ever~increasing doses of the stronger, more debilitating neuroleptics. The scope of rhe harm is immense. Ir is likely the toll grearly exceeds rhar from Vioxx. The neuroleprics, old and new, disable many people who take rhem and subsranrially reduce life spans (Joukama er ai., 2006; Srraus er ai., 2004; Waddingron er ai., 2003). Similarly, it has been reliably estimated the antidepressants have caused 23,000 suicides (Healy, 2004). These facts are virtually never disclosed to patients, thus breaching the obligation to obrain informed consent, and often legally consriruring barrery. In forced drugging proceedings, psychiatrists testifying as witnesses regularly testify untruthfully, which consti rures perjury. This resulrs in rhe courrs being duped inro forcing hundreds of rhousands of unwilling people to rake harmful drugs. The rhrear of involunrary commirmenr for failure to comply keeps many more taking these drugs in spite of their desire to reduce or eliminate them. People's lives are being ruined and shortened needlessly, because there are better alternatives. The legal system has not yet done much to hold psychiatrists account able for rhis harm, bur rhat may change Springer Publishing Company il7

2 lib GOltstein PSYCHIATRIC DRUGS: THE FACTS The disability rate of people diagnosed with mental illness in the United States has increased six~fold since the introduction of the supposed miracle drug Thorazine in 1955 to treat people diagnosed with schizophrenia (Whitaker, 2005). Thorazine and its cousins, Prolixin, Mellaril, Navane, Trilafon, Stelazine, Haldot, and so forth, are often referred [Q as the classic neuroleptics. whose allure has largely faded with the expira~ tion of their patents. They cause tardive dyskinesia (TO), which is a largely irreversible movement disorder, at a rate of approximately 5% per year of drug exposure (Breggin, 1997; jackson, 2005), and neuroleptic malignant syndrome (NMS), which is an often fatal disease characterized by muscular rigidity and high fever (Pelonero, Levenson, & Pandurangi, 1998). Starring in 1990, a new generation of neuroleptics was introduced for the treatment of schizophrenia, including Clozaril, Zyprexa, Risperdal, Seroquel, and Abilify. These drugs are termed "atypicals" because they supposedly have lower toxicity and are more effec~ tive. Neither of these marketing assertions has proven true (Lieberman et ai., 2005). In addition to it being entirely unclear that these drugs cause less tardive dyskinesia or neuroleptic malignant syndrome (Srip, 2002), this class ofdrugs is causing massive amounts ofdiabetes and other metabolic problems (Ananth, Venkatesh, Burgoyne, & Gunatilake, 2002; Berenson, 2006). The latest trend is to use the drugs on children, particularly those in state custody, with devastating effects on their health and lives (Bittigau, er al., 2002; Olney, Farber, Wozniak, jevrovic-todorovic, & Ikonomidou, 2000). These drugs are also deadly, with a recent study concluding they increase mortality by 2.5 times for each drug prescribed (Waddington et ai., 2003). For most patients these drugs are terrible to experience. At common doses. they [urn people into zombies, often cause an uncontrollable agitation, called ahathisia, which can be so distressing it causes people to kill themselves (or get violent) (American Psychiatric Association, 2000), and, as mentioned, create serious health problems. They also often do not even help much with the Upositive symptoms," such as hearing voices and delusions (jackson, 2005). The tragedy is that nonmedication approaches have been shown to work, leading to much better lives for many people (e.g. Karon & Vandenbos, 1996; Mosher, 1999). In fact, a conservative estimate is the current pervasive reliance on psychiatric drugs for the treatment ofschizophrenia is at least doubling the number of people who become permanently disabled (Whitaker, 2002, 2005). 11,e reality is these drugs are most often used by the mental health system to subdue and control individuals whose behavior is disturbed and/or disturbing. The courts have been enlisted to force these drugs on unwilling patients in proceedings that can fairly be termed shams and in which the psychiatrists testifying in favor of the forced drugging regularly commit perjury. Before discussing forced psychiatric drugging, however, it has been esti~ mated SSRI antidepressants, such as Prozac, Paxil, and Zoloft, cause psychotic reactions in 5%-20% of patients, who then often are misdiagnosed with serious memal illness rather than having the problem attributed to the drug (Breggin, 2003; Whitaker, 2005). The same process ofpsychotic reaction, often leading [Q diagnoses ofserious mental illness, occurs with the stimulants, such as Ritalin, given [Q children to control them after being diagnosed with ADHD. Current estimates of psychotic reactions [Q these ADHD drugs are in the 5%-10% range (Breggin, 2002; jacbon, 2005).

3 Psychiatric Dmgs 1/9 COURT-ORDERED PSYCHIATRIC DRUGGING People have a fundamental, although not absolute, tight undet the 14th Amendment to be free of unwanted psychiatric drugs (Mills v. Ragas, 1982; Unired Scares v. Sell, 2003; Wmhingron v. Harper, 1990). In Mills v. Rogers, the United States Supreme Court held the constitucional protection under the 14th Amendment of the United Stares Constitution is intertwined with state law, and if state rights are broader than federal constitutional protec~ tions, the state rights "would define the actual [fedetal] substantive tights possessed by a person living within that State." Court~ordered psychiatric drugging arises in a number of contexts. The most common are civil inpatient and outpatient commitment proceedings, competence to stand trial proceedings, and in prisons. The U.S. Supreme Court case of Sell v. United States involved competence to stand trial, and defined the federal constitutional protections in that setting. The U.S. Supreme Court has never ruled on the precise p:j.rame~ ters of 14th Amendment rights in the civil context, but because of its use of well-established constitutional principles, the following rules it announced are presumably applicable First, a coun must find that important governmental interests nre at stake. Second, the court must conclude that involuntary medication willsignificandy further those concomitant state interests. Third, the court must conclude that involuntary medication is nece.ssary to further those interests. ll1c court must find that any alternative, less intrusive treatments are unlikely to achieve subst::mtially the s::une results. Fourth,... the court must conclude that administration of the drugs is medically approprim/!, that is, in the patient's best medical interest in light of his medical condition (United States v. Sell, 2(03). In the civil context, except in emergencies, it is only someone who has been found incompetent to make the decision who can be court ordered to submit to psychiatric drugs (Rivers v. Katz, 1986). Where such a determination has been made and without relying on Sell, the Alaska Supreme Court recently utilized the same sort of analysis as contained in Sell in finding Alaska's forced drugging unconstitutional for failure to require the court to find the drug(s) in the patient's best intercst and there are no less restrictive alcernatives avail~ able (Myers v. Alaska Psychiatric lnsti"'te, 2006). The governmental intetests involved are public safety, exercised under the "police power," which is restricted to short~term emer~ gency situations, and the second is to act in the best interests ofsomeone who is incompetent under what is called the parcns IXJtriae doctrine, which basically means the state is stepping in and acting on behalfofsomeone as would the parent ofa minor. In light ofthe dubious, at best, efficacy ofthe drugs, and the extreme harm they cause, it does not seem possible to actually meet the best interests standard. However, the pervasive message that these drugs are safe and effective, including meretricious court testimony by psychiatrists, results in the courts and the attorneys assigned to represent psychiatric defendants giving short shtift to people's rights. People's rights are dishonored m a matter of course in these proceedings. Psychiattist E. Fuller Torrey (1997) touts psychiatrists' lying to the courts: "It would probably be difficult to find any American Psychiattist working with the mentally ill who has not, at a minimum, exaggerated the dangerousness of a mentally ill person's behavior to obtain a judicial order for commitment." (152) Dt. Torrey also quotes psychiatrist Paul Applebaum as saying when "confronted with psychotic persons who might well benefit

4 120 Gottstein from treatment, and who would certainly suffer without it, mental health professionals and judges alike were reluctant to comply with the law," noting that in '''the dominance of the commonsense model,' the laws ace sometimes simply disregarded." ( 151). This has also been recognized by perhaps the leading commentator on this area of the law, New York Law School professor Michael Perlin (1993/1994): Courts accept... testimonial dishonesty,... specifically where witnesses. especi::jlly expert witnesses, show a "high propensity [0 purposely distort their testimony in order ro achieve desired ends."... Expects frequendy... and openly subvert statutory and case law criteria that impose rigorous behavioral smndards as predicates for commitment... This combination... helps define a system in which (1) dishonest testimony is often regularly (and umhinkingly) accepted; (2) S[atucory and case law standards are frequently subverted; and (J) insurmountable harriers are raised CO insure that the allegedly "therapeutically correct" social end is met... In shorr, the mental disability law system often deprives individuals of liberty disingenuously and upon bases thar have no relationship to case law or to statutes. Psychiatrists have largely gotten away with this thus far because of the prevailing attitude that protesting patients are just crazy and don't know what is good for them. However, this free ride may come to an end fairly soon. CONSENT, INFORMED CONSENT, BATTERY, AND THE RIGHT TO SELF-DETERMINATION At common law the failure to obtain consent is battery (Hull, 2002): [A]n unconsented touching is a battery under the law, apart from exceptional, emergency situations where consent is presumed physicians need their patients' consent in order to ply their craft. Absem such consem, surgery becomes stabbing, chemotherapy becomes poisoning, and urological examinations become sexual assaults. Nor is [he defense ofgood intemions a sufficient excusing factor. The consem of the patient is recognized in the law as essential, and the provision of unwanted medical care is not excused by the benevolent intentions of the provider. This common law rule has been changed by statute in some stares, although the Arizona Supreme Court recently struck down such a state statute (Duncan tj. Scou.sdare Medical Imaging, 2003). Some states make the distinction between total lack of consent, which they find constitutes battery, and failu~e to obtain infonned consent, i.e., failing to provide adequate information, which is considered malpractice rather than bmtery (e.g., Cobbs v. Grant, 1972). Other states hold that failure to obtain infonned consent does constitute battery (Shadrick v. Coker, 1998). In still other states, even the lack ofany consent is considered a malpractice claim, not battery (L"genb"h/ v. Dowling, 1997). To confuse the matter even more, in the LHgenbuhl case, which ruled the lack of any consent at all is a medical malpractice claim, not battery, the Louisiana Supreme Court stated where there was failure to obtain such consent "some of the damages generally awarded in battery cases are appli~ cable," holding "damages for deprivation ofselrdetermination, insult to personal integrity, invasion of privacy, anxiety, worry and mental distress are actual and compensatory." All of this is unnecessarily confusing, because the bottom line is psychiatrists are finan~ cially liable for failure to obtain informed consent.

5 Psychiatric Dmgs 121 Before this topic is left, however, a couple of points should be made about what seems to be an inconsistent body oflaw. First, case law develops from the specific fac 5 in the case at hand and different facts can cause distinctions to be drawn with different resul 5. Second, the underlying assumption in the courts considering these cases to be malpractice, rather than battery, is based on the premise the failure to obtain informed consent was uninten~ tional. To the extent infonnation necessary to informed consent is deliberately withheld, or false information given, then this logically moves the situation back into the battery arena as an intentional act, which was recognized in the Duncan v. Scottsdale Medical Imaging case. In this regard, reckless disregard, is the same as an intentional act. In other words, it is a battery where the truth was not told to the patient because the prescribing physician recklessly failed to apprise him or herself of the actual benefits and harms, or even made a "substantial mistake." WHAT IS INFORMED CONSENT? As with whether failure to obtain consent or informed consent is a battery or malpractice, states vary as to what constitutes informed consent. Cobbs 'v. Gram (1972) is consid~ ered to have a good discussion of the general law: [Aln integral part of the physician's overall obligation to the patient... is a duty of reasonable disclosure ofthe available choices with respect [Q proposed therapy and ofthe dangers inherently and potentially involved in each. A concomitant issue is the yardstick co be applied in determining: reasonableness ofdisclosure. This defendant and the majority ofcourts have rehued the duty to the Custom of physicians prac~ ticing in the community. The majority rule is needlessly overbroad. Even if there can be said to be a medical community standard as to the disclosure requirement (or any prescribed treatment, it appears so nebulous that doctors become, in effect, vested with virtual absolute discretion... 'Nor can we ignore the fact that to bind the disclosure obligation to medical usage is to arrogate the decision on revelation to the physician alone. Respect (or the patient's right of self detcrmi~ nation on particular therapy demands a standard set by law for physicians rather than one which physicians mayor may not impose upon themselves.' Unlimited discretion in the physician is irreconcilable with the basic right of the patient to make the ultimate informed decision regard~ ing the course of treatment to which he knowledgeably consents to be subjected.".. A mini course in medical science is not required; the pntient is concerned wim the risk of death or bodily harm, and problems of recuperntion. Second, there is no physician's duty to discuss the relatively minor risks inherent in common procedures, when it is common knowledge that such risks inherent in the procedure are of very low incidence... [\'{!]hen a given procedure inherently involves a known risk ofdeath or serious bodily harm, a medical doctor has a duty to disclose to his patient the potential of death or serious harm, and to explain in lay terms the complications that might possibly occur. Beyond the foregoing minima! disclosure, a doctor must also reveal to his patient such additional information as a skilled practi~ tioner of good standing would provide under similar circumstances. In sum, the patient's right ofself decision is the measure ofthe physician's duty to reveal. That right can be effectively exercised only if the patient possesses adequate information to enable an intelligent choice. The scope of the physician's communications to the patient, then, must be measured by the patient's need, and that need is whatever information is material to the decision. Thus the test for determining whether a potential peril must be divulged is its materiality to the patient's decision.

6 /22 Gottstein Under Alaska Statutes (1992), pertaining to the administration of psychotropic drugs, uinformed" is defined to mean "that the evaluation facility or designated treatment facility has given the patient all information that is material to the patient's decision to give or withhold consent, including (A) an explanation ofthe patient's diagnosis and prognosis, or their predominant symptoms, with and without the medication; (B) information about the proposed medication, its purpose, the method of its administration, the recommended ranges of dosages, possible side effects and benefits, ways to treat side effects, and risks of other conditions, such as tardive dyskinesia; (C) a review of the patient's history, including medication history and previous side effects from medication; (0) an explanation of interactions with other drugs, including ovehhe~counrer drugs, street drugs, and alcohol; (E) information about alternative treatments and their risks, side effects, and benefits, including the risks of nonrreatment... This raises the question of what liability might attach to psychiatrists' failure to obtain informed consent. PSYCHIATRISTS' POTENTIAL EXPOSURE Space does not allow a full discussion of potential causes of actions which might be brought against psychiatrists, but a few thoughts about various types of lawsuits will be presented. Tort Litigation In spite of the harm being caused by neuroleptics, with rare exceptions, people injured by them have an extraordinarily hard time obtaining representation for personal injury cases. One reason is the belief that victims had little prospect of earning significant income. However, it is simply not true that people diagnosed with serious mental il1~ ness have to have low to nonexistent economic prospects. It would be surprising if any reader was not aware of a bright college or graduate student who had a breakdown while in school, was put on psychiatric drugs, and never returned to what could have been a very successful life path. Many, or even most, of these bright, competent, high~achieving young adults, with real help (or many even if left to their own devices), could and would have recovered to fulfill their potential. Their economic loss from being permanently disabled by neuroleptics is substantial. For states where battery is the cause of action, damages are presumed. We have recently seen at least one billion-dollar case, and some close to that, against drug manufacturers for failure to tell the truth about psychiatric drugs. As the warn"" ings about these drugs become sufficient, liability shifts to the psychiatrists who don't provide sufficient information to obtain infonned consent. Another potential category of personal injury cases is when the drugs have caused someone to commit suicide or a vio~ lent act against someone else. It is well established that the neuroleptics and the SSRI

7 Psychiarric Dmgs 123 antidepressants cause suicide or violence, including homicide. The amount of damages (liability) in such cases can be substantial because there often is a very well~established earnings loss. Perhaps the most heartbreaking class of potential cases are those where children have been psychiatrically drugged. More and more, and younger and younger children are being prescribed neuroleptics, which have never been approved for such use. (Olfson, Blanco, Liu, Moreno, & Laje 2006). The health impacts, including brain damage, will be substantial. It is not unlikely that the tremendous increase in prescribing atypical neuroleptics to children is a significant contributor to the increase in U.S. pediatric diabetes. The damages (liability) for this can be enormous. Federal Civil Rights Litigation Under 42 U.S.C. 1983, anyone who violates a citizen's constitutional rights "under color ofstate law" can be sued for damages in federal court. Psychiatrists whoobtain coun orders to forcibly medicate their patients without providing the court with sufficient information to make an informed decision whether it is in the patient's best interest to be forcibly medicated have presumably violated their patients civil rights under color ofstate law and are liable in damages. Qui Tam or Private Attorney General Litigation Perhaps ofeven greater potential are the numerous statutes, sometimes referred to as qui ram, allowing private citizens w sue for a penalty, part ofwhich the government or some specified public institution will receive. There appears to be a massive amount ofwhat can be labeled~ Medicaid/Medicare fraud associated with the prescribing of these drugs, and this is another potential source of liability. Securities Fraud Under federal securities law it is illegal to make any untrue statement ofa material fact or omit a material fact or engage in any act that would operate as a fraud or deceit in connec~ tion with the purchase or sale of securities (Securities Exchange Act Rules, 1934). The Sarbanes Oxley Act (2002) also imposed liabilities on corporate officials. Psychiatrists who publish misleading articles that overstate the benefits and understate the harm could potentially be liable for astronomical amounts of damages to shareholders when stock prices drop after the facts come out. CONCLUSION For various reasons, psychiatrists have nor heretofore often been held legally responsible for their failure to adequately infonn their patients about the true efficacy and known harms of the drugs they prescribe with ubiquity. This has likely lulled them into a false sense of security because there are various facwrs at work, which could loose a tidal wave of legal cases against those who do not adequately inform their patients about the benefits and harms, including the efficacy ofother approaches and of nontreatrnent.

8 124 Gormcin REFERENCES Alaska Statutes , 8 chapter 109 Session Laws of Alaska (1992). American Psychiatric Association. (2000). Diagnostic and statistical manllal of meneal disorders (4th ed., text rev.). Washingron, DC: Author. Ananth, ]., Venkaresh, R., Burgoyne, K., & Gunatilake, S. (2002). Atypical antipsychotic drug use and diabetes. Ps)'chorhcrapy and PS)'cllOSOmarics, 71, Berenson, A. (2006, December 17). Eli Lilly said to play down risk of top pill. New York Times, p. AI. Bittigau, P., Sifringer, M., Gem, K., Reith, E., Pospischil, D., Govindarajalu, S., et al. (2002). Ami~ epileptic drugs and apoproric neurodegeneration in the developing brain. Proceedings of the National Academy of Sciences of the Unired Slates, Breggin, P. (1997). Brain~djsablingtreatments in psychiatry: DTl/gs, elecrros}wcl" and rhe role of the FDA. New York: Springer Publishing. Breggin, P. (2002). The Ritalin facr book. New York: Perseus Publishing. Breggin, P. (2003). Suicidaliry, violence, and mania caused by selective serotonin reuptake inhibitors (SSRIs): A review and analysis.lmemationaljol/maiofrish and Safery in Medicine, 16, Cobbs v. Grant, 502 P.2d 1 (1972) Duncan v. Scattsdale Medical Imaging, 70 P.3d 435 (Ariz 2003). Healy, D. (2004). Lerter to FDA: Updated suicidal evidence not adflressed by FDA. Retrieved April 1, 2004, from Hull, R. (2002). The alchemy of informed consent. The JOllmal ofclinical Erhics, 13( 1), Jackson, G. (2005). Rerhinhingps)'chiarric dtiigs: AgHide ro infonned consent. Bloomington, IN: Author House. Joukamaa, M., Helovaara, M., Kneh, P., Vaara, H., Aromaa, A., Ratasalo, R., et a1. (2006). Schizophrenia, neuroleptic medication, and mortality. British journal of Psychimry, 188, Karon, B., & Vandenbos, G. (1996). PsycllOrllerapy of schizophrenia: Tile rrearmenc of choice. New York: Jason Aronson. Lieberman, J., Stroup, T, McEvoy, J., Swartz, M., Rosenheck, R., Perkins, D., et al. (2005) Effec, tiveness of antipsychotic drugs in patients with chronic schizophrenia. New England Journal of Medicine, 353, Lugenbuhl v. Dowling, 701 So.2d 447 (La. 1997). Mills v. Roger.s, 457 U.S. 291, (1982). Mosher, L (1999). Soteria and other alternatives to acute psychiatric hospitalization: A personal and professional review. The Journal of NeTt'OIIS and Meneal Disease, 187, Myers v. Alasl", Psychiarric Insritllre, 138 P.3d 238 (Alaska 2006). Olfson, M., Blanco, c., Liu, L, Moreno, D., & Laje, G. (2006). National trends in the outpatient treatment of children and adolescents with antipsychotic drugs. Archives of General ps)'chiarry, 63, Olney, j., Farber, N., Wozniak, D., Jevtovic,Todorovic, v., & Ikonomidou, C. (2000). Environ~ mental agents that have the potential to trigger massive apoptotic neurodegeneration in the developing brain. Environmental Health Perspecti,ves, 108, Pelonero, A., Levenson, J., & Pandurangi, A. (1998). Neuroleptic malignant syndrome: A review. P$ychiarric Services, 49, Perlin, M. (1993/1994). The ADA and persons with mental disabilities: Can sanist attitudes be undone? journal oflaw and Healrh, 8, IS. Rivers v. Katz, 495 N.E.2d 337, 343 (NY 1986). Sarbanes-Oxley Act of 2002, PL , 15 USCA 7201, et. seq. Securities Exchange Act Rules (1934), 17 C.ER. 240.lOb-5. Shadrick v. Colcer, 963 S.W.2d 726 (Tenn. 1998). Stip, E. (2002). Happy birthday neuroleptics! 50 years later: La folie du doure. EurojJean Psychiatry, 17,1-5.

9 Psychiatric Dmgs 125 Straus, S., Bleumink, G., Dieleman,J., van der Lei, J., 'tjong, G., Kingma, J., et al. (2004). Antipsy~ choties and the risk of sudden cardiac death. ArchilJCS of InremaI Medicine, 164, Torrey, E. (L997). Out of the shadows: Confronting America's mental illness crisis. New York: John \Viley and Sons. Uniled Sflll<S v. S,Il, 539 U.S. 166 (2003). Waddington, ]., Morgan, M., Scully, P., Youssef, H., Kinsella, A., & Owens, J. (2003). Prospective analysis of premature mortality in schizophrenia in relation to health service engagement: A 7.5 year study within an epidemiologically complete homogenous population in rural Ireland. Psychiaery Research, 117(2), Washington v. Harper, 494 U.S. 210 (1990). Whitaker, R. (2002). Mad in America: Bad. science, Ixu1. medicine, and the enduring mistreatment of the menrally ill. New York: Perseus Publising. Whitaker, R. (2005). Anatomy ofan epidemic: Psychiatric drugs and the astonishing rise of mental illness in America. Ethical Human Psychology and Psychiatry, 7(1), Correspondence regarding this article should be directed to James B. Gottstein, Esq., JO, 406 G Street, Suite 206, Anchorage, AK E mail:

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